Non-small Cell Lung CancerPhase 1/2NCT04444427
Evaluation of GLR2007 for Advanced Solid Tumors
A Phase 1/2 study testing GLR2007 in people with Non-small Cell Lung Cancer and Glioblastoma Multiforme, run by Gan and Lee Pharmaceuticals, USA at 4 sites in United States.
Trial summary
Evaluation of GLR2007 for Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Glioblastoma Multiforme
- What is being tested?
- GLR2007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jul 2020to 29 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Part 1 (Dose Escalation): Participants with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit.
- For Part 1 (Dose Escalation): The participant must have histological or cytological evidence of cancer (a solid tumor) that is advanced and/or metastatic. Biopsy is allowed by protocol if no histology or cytology records are available.
- For Part 2 (Dose Expansion): The participant must have histological or cytological evidence of cancer that is advanced and/or metastatic.
- For Part 1 (Dose Escalation): The participant has measurable or non-measurable disease.
- For Part 2 (Dose Expansion): The participant has measurable disease.
- The participant has given written informed consent prior to all study-specific procedures.
Show all 30Show fewer
- The participant has adequate hematologic, hepatic, and renal function.
- The participant has discontinued all prior cancer therapies (including chemotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for radiotherapy and non-myelosuppressive agents, prior to receiving GLR2007, and has recovered from the acute effects of therapy (treatment related toxicity resolved to ≤Grade 1) except for residual alopecia.
- The participant is willing and able to make themselves available for the duration of the study and is willing and able to follow study procedures.
- The participant meets contraceptive requirements.
- The participant has an estimated life expectancy of ≥3 months.
- The participant agrees to minimize ultraviolet exposure and sunlight for the duration of their study participation.
- A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed within 28 days prior to registration. Contrast-enhanced computed tomography (CT) is acceptable if MRI is not possible.
- Cohort-specific inclusion criteria Part 2 (Cohort A, NSCLC)
- Histologically or cytologically confirmed NSCLC.
- Participants must have received at least 1 line of standard therapy for metastatic disease, including platinum-based chemotherapy and an immune checkpoint inhibitor given together or as separate lines of therapy, unless participants are ineligible for or cannot tolerate such therapy.
- Participants with anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), proto-oncogene tyrosine-protein kinase ROS (ROS1), v-Raf murine sarcoma viral oncogene homolog B (BRAF), and neurotrophic receptor tyrosine kinase 1 (NTRK) aberrations must have received therapy directed at their molecular aberration in order to enroll on this study.
- Part 2 (Cohort B, Brain metastases of breast or NSCLC origin)
- Histologically or cytologically confirmed NSCLC or breast cancer at primary site.
- Participants with inoperable brain metastases (prior radiation therapy and/or stereotactic radiosurgery is allowed). A neurosurgical consult is at the discretion of the investigator.
- Participants with brain metastases of NSCLC origin must have received at least 1 line of standard therapy for metastatic disease, including platinum-based chemotherapy and an immune checkpoint inhibitor given together or as separate lines of therapy, unless participants are ineligible for or cannot tolerate such therapy.
- Participants with ALK, EGFR, ROS1, BRAF, and NTRK aberrations must have received therapy directed at their molecular aberration in order to enroll on this study.
- Participants with brain metastases from breast cancer who have previously received CDK4/6 inhibitors.
- Part 2 (Cohort C, GBM)
- Histologically confirmed diagnosis of a recurrent primary World Health Organization Grade IV malignant glioblastoma. Participants with recurrent disease whose diagnostic pathology confirmed glioblastoma will not need re-biopsy. Participants with prior low-grade glioma or anaplastic glioma are eligible if histologic assessment demonstrates transformation to GBM.
- First recurrence of GBM.
- Candidate for surgical partial or gross-total resection.
- Radiographic demonstration of disease progression by contrast-enhanced CT or MRI following prior therapy.
- At least 2 weeks between prior surgical resection and adequate wound healing.
- At least 12 weeks from prior radiotherapy unless there is either histopathologic confirmation of recurrent tumor or new enhancement on MRI outside of the treatment field.
Who cannot join
- The participant has a personal history of any of the following conditions: major surgical resection involving the stomach or small bowel recurrent, unexplained or cardiac-related syncopal episodes within the last 6 months or ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation).
- Any concurrent malignancies currently requiring treatment or for which treatment would be deemed necessary within 3 months of enrollment; prostate cancer with androgen deprivation therapy, basal cell cancer, and squamous cell cancers are allowed.
- The participant is pregnant or lactating.
- The participant is immunocompromised and known to be human immunodeficiency virus positive. The participant has an active bacterial, fungal, and/or known viral infection (for example, hepatitis B surface antigen or hepatitis C antibodies).
- Cohort-specific exclusion criteria:
- Part 2 (Cohort A, NSCLC): The participant has NSCLC with worsening symptoms within 14 days prior to receiving GLR2007.
- Part 2 (Cohort B, Brain metastases of breast or NSCLC origin): The participant has CNS metastasis with worsening symptoms within 14 days prior to receiving GLR2007.
- Part 2 (Cohort C, GBM): The participant has GBM with worsening symptoms within 14 days prior to receiving GLR2007.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
USA004
Dallas, Texas, 75230
USA002
Lafayette, Indiana, 47905
USA005
Omaha, Nebraska, 68130
USA001
Philadelphia, Pennsylvania, 19111
About this study
Official title: An Open-Label, Multicenter, Phase 1b/2 Study to Establish Safety, Tolerability, and Optimal Dosing Strategy of GLR2007 in Subjects With Advanced Solid Tumors
Evaluation of GLR2007 for Advanced Solid Tumors
Read the detailed description
An Open-Label, Multicenter, Phase 1b/2 Study to Establish Safety, Tolerability, and Optimal Dosing Strategy of GLR2007 in Subjects with Advanced Solid Tumors
- Being tested
- GLR2007
- Keywords
- Non-small Cell Lung Cancer, Glioblastoma Multiforme, Breast Cancer, Advanced Solid Tumors, GLR2007
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Glioblastoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLR2007Drug
Also called GLR2007-237FA
Administered orally, once daily for 21 days followed by a 7-day treatment holiday.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Dose escalation cohorts are planned to determine the maximum tolerated dose or recommended phase 2 dose of GLR-2007, as well as expansion cohorts and a Phase 2 cohort. Receives: Drug: GLR2007 |
| Part 2: Dose Expansion - Cohort A | Experimental | Participants who have received 2 or more second-line therapies, with at least 1 line of standard therapy, for their non-small cell lung cancer (NSCLC) will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression. Receives: Drug: GLR2007 |
| Part 2: Dose Expansion - Cohort B | Experimental | Participants who have received 2 or more second-line therapies, with at least 1 line of standard therapy, for their brain metastases of breast or NSCLC origin will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression. Receives: Drug: GLR2007 |
| Part 2: Dose Expansion - Cohort C | Experimental | Participants experiencing their first recurrence glioblastoma multiforme (GBM) will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression. Receives: Drug: GLR2007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Dose-limiting Toxicities
Measured: Up to 12 Months
Dose Escalation: Incidence And Severity Of Adverse Events, Including The Incidence Of Dose-limiting Toxicities Within The First Cycle
Measured: Up to 12 Months
Dose Expansion: Incidence And Severity Of Adverse Events
Measured: Up to 96 Weeks
Secondary outcomes (8)
Dose Escalation: Objective Response Rate
Defined by response evaluation criteria in solid tumors (RECIST) Version 1.1 (solid tumors) or by response assessment in neuro-oncology (RANO) (brain metastases and GBM).
Measured: 8 Weeks
Dose Expansion: Objective Response Rate
Defined by RECIST Version 1.1 or by RANO as appropriate.
Measured: 12, 24, 36, 48, 60, 72, 84, and 96 Weeks
Dose Escalation And Expansion: Maximum Observed Plasma Concentration After Single And Multiple Oral Dose Administrations
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Time At Which Maximum Plasma Concentration Is Observed And Apparent Half-life After Single And Multiple Oral Dose Administrations
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Area Under The Plasma Concentration-time Curve From 0 To Last Measurable Concentration And From 0 To Infinity After Single And Multiple Oral Dose Administrations
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Accumulation Ratio After Single And Multiple Oral Dose Administrations
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Steady-state Volume Of Distribution After Single And Multiple Oral Dose Administrations
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Clearance After Single And Multiple Oral Dose Administrations
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start15 Jul 2020
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1 employs a dose-escalation design to determine the recommended phase 2 dose. This is followed by Part 2, which involves parallel dosing of 3 different cohorts at the dose determined in Part 1.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Lazaroff, MSN, Study director, Gan and Lee Pharmaceuticals, USA Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444427
- Sponsor's protocol ID
- GLP-CDK-1009
- Status last verified
- Jul 2022
- First submitted
- 19 Jun 2020
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1b/2 Study to Establish Safety, Tolerability, and Optimal Dosing Strategy of GLR2007 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04444427
- Acronym / sponsor ID
- GLP-CDK-1009
- Keywords
- Non-small Cell Lung Cancer, Glioblastoma Multiforme, Breast Cancer, Advanced Solid Tumors, GLR2007
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of GLR2007 for Advanced Solid Tumors
Detailed description
An Open-Label, Multicenter, Phase 1b/2 Study to Establish Safety, Tolerability, and Optimal Dosing Strategy of GLR2007 in Subjects with Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Part 1 employs a dose-escalation design to determine the recommended phase 2 dose. This is followed by Part 2, which involves parallel dosing of 3 different cohorts at the dose determined in Part 1.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: GLR2007Dose escalation cohorts are planned to determine the maximum tolerated dose or recommended phase 2 dose of GLR-2007, as well as expansion cohorts and a Phase 2 cohort. |
| Part 2: Dose Expansion - Cohort A | Experimental | Drug: GLR2007Participants who have received 2 or more second-line therapies, with at least 1 line of standard therapy, for their non-small cell lung cancer (NSCLC) will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression. |
| Part 2: Dose Expansion - Cohort B | Experimental | Drug: GLR2007Participants who have received 2 or more second-line therapies, with at least 1 line of standard therapy, for their brain metastases of breast or NSCLC origin will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression. |
| Part 2: Dose Expansion - Cohort C | Experimental | Drug: GLR2007Participants experiencing their first recurrence glioblastoma multiforme (GBM) will be dosed the maximal tolerated dose of GLR2007 as determined in Part 1 until lack of tolerance or disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- For Part 1 (Dose Escalation): Participants with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit.
- For Part 1 (Dose Escalation): The participant has measurable or non-measurable disease.
- For Part 2 (Dose Expansion): The participant has measurable disease.
- The participant has given written informed consent prior to all study-specific procedures.
- The participant has adequate hematologic, hepatic, and renal function.
Key exclusion criteria (8 listed)
- The participant has a personal history of any of the following conditions: major surgical resection involving the stomach or small bowel recurrent, unexplained or cardiac-related syncopal episodes within the last 6 months or ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation).
- Any concurrent malignancies currently requiring treatment or for which treatment would be deemed necessary within 3 months of enrollment; prostate cancer with androgen deprivation therapy, basal cell cancer, and squamous cell cancers are allowed.
- The participant is pregnant or lactating.
- The participant is immunocompromised and known to be human immunodeficiency virus positive. The participant has an active bacterial, fungal, and/or known viral infection (for example, hepatitis B surface antigen or hepatitis C antibodies).
- Part 2 (Cohort A, NSCLC): The participant has NSCLC with worsening symptoms within 14 days prior to receiving GLR2007.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLR2007Also: GLR2007-237FAAdministered orally, once daily for 21 days followed by a 7-day treatment holiday. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion - Cohort A, Part 2: Dose Expansion - Cohort B, Part 2: Dose Expansion - Cohort C |
Primary outcome
Dose Escalation: Dose-limiting Toxicities
Time frame: Up to 12 Months
Dose Escalation: Incidence And Severity Of Adverse Events, Including The Incidence Of Dose-limiting Toxicities Within The First Cycle
Time frame: Up to 12 Months
Dose Expansion: Incidence And Severity Of Adverse Events
Time frame: Up to 96 Weeks
8 secondary outcomes
Dose Escalation: Objective Response Rate
Time frame: 8 Weeks
Dose Expansion: Objective Response Rate
Time frame: 12, 24, 36, 48, 60, 72, 84, and 96 Weeks
Dose Escalation And Expansion: Maximum Observed Plasma Concentration After Single And Multiple Oral Dose Administrations
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Time At Which Maximum Plasma Concentration Is Observed And Apparent Half-life After Single And Multiple Oral Dose Administrations
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Area Under The Plasma Concentration-time Curve From 0 To Last Measurable Concentration And From 0 To Infinity After Single And Multiple Oral Dose Administrations
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Accumulation Ratio After Single And Multiple Oral Dose Administrations
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Steady-state Volume Of Distribution After Single And Multiple Oral Dose Administrations
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Dose Escalation And Expansion: Clearance After Single And Multiple Oral Dose Administrations
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Lazaroff, MSN study director
Gan and Lee Pharmaceuticals, USA Corp
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLR2007 in people with Non-small Cell Lung Cancer and Glioblastoma Multiforme, run by Gan and Lee Pharmaceuticals, USA at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Dose-limiting Toxicities (time frame: Up to 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.